Compared the efficacy of mitoxantrone hydrochloride injection for tracing with radionuclide in sentinel lymph node biopsy of breast cancer.

Background and purpose: Both domestic and foreign guidelines recommend the use of radionuclide as sentinel lymph node (SLN) biopsy (SLNB) tracer, however this technique has not been popularized in China for a variety of reasons. Mitoxantrone hydrochloride injection for tracing (MHI), a new strategy to identify lymph nodes, has not been tested for axillary node staging in breast cancer. This multicenter, self-controlled, non-inferiority trial aimed to evaluate the differences between MHI and radionuclide in SLNB tracing. Methods: The trial was conducted across 7 hospitals from December 2019 to December 2020. Patients with early-stage breast cancer received MHI and radionuclide (technetium 99 labeled sulfur colloid, 99mTc-Sc) as SLN tracers during the surgery. The number of SLNs detected and sentinel node detection rates of MHI and radionuclide were counted to evaluate differences in the tracing effects between the two tracers. Results: SLN detection rates of MHI and radionuclide were 96.9% (370/382) and 97.4% (372/382), respectively, with no significant difference (P>0.05). SLNs were co-detected by both tracers in 362 (94.7%) patients; 16 (4.1%) had adverse events possibly related to the trial drugs. Conclusion: In this study, it was found that the lymphatic tracing ability of MHI was not inferior to that of radionuclide. Meanwhile, the use of MHI does not require special instrument/ equipment assistance. [ABSTRACT FROM AUTHOR]